Kornimate/medical-research-clean huggingface dataset:
dose finding study for qaw039 in asthma

Conditions: Asthma

Summary: this study aims to demonstrate a clinically significant improvement in forced expiratory volume in one second (fev1) in moderate to severe allergic asthmatics inadequately controlled by inhaled corticosteroid (ics) therapy. patients will be treated with qaw039, an active comparator, or placebo. this will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.


Eligibility criteria:
inclusion criteria: * physician diagnosis of asthma, as per the global initiative for asthma (gina) (2009) guidelines, and currently prescribed inhaled corticosteroids (ics) therapy. * patients with a pre-bronchodilator forced expiratory volume in 1 second (fev1) value of 40% to 80% of individual predicted value. * patients should be allergic or atopic, as diagnosed historically or prior to entry into the study. * patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year. * an asthma control questionnaire (acq) score ≥ 1.5 at randomization. exclusion criteria: * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hcg) laboratory test (\> 5 miu/ml). * patients with serious co-morbidities including uncontrolled diabetes (hba1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. churg-strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.). * acute illness other than asthma at the start of the study * history of life-threatening asthma, including a history of significant hypercarbia (pco2\>45mmhg), prior intubation, respiratory arrest, or seizures as a result of asthma. * patients who have had a respiratory tract infection within 4 weeks of the screening visit. patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date. * current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Keywords: asthma qaw039
safety and efficacy of combining intranasal insulin & acute exercise

Conditions: Insulin; Exercise

Summary: to determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 iu of novolog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. the efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. the safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Eligibility criteria:
inclusion criteria: 1. participants must be over the age of 18.. 2. participants must have normal or corrected-to-normal vision in order to complete the cognitive task. exclusion criteria: 1. lack of consent. 2. presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire. 3. type i or type ii diabetes 4. self-reported pregnancy 5. currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Keywords: intranasal insulin cognition exercise physical activity
the role of ultrasound in covid-19

Conditions: COVID-19

Summary: the study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater copenhagen with a laboratory confirmed diagnosis of covid-19. the investigators aim to examine if echocardiography - both conventional and advanced - can be used to predict which patients will develop acute respiratory distress syndrome (ards) or other short-term acute complications, especially focusing on cardiovascular outcomes. in addition, using a novel technique of lung ultrasound (lus), the investigators aim to analyze specific lus-findings, and associate them with short-term prognosis and development of ards and long-term cardiovascular morbidity and mortality. in all patients included, the investigators aim to examine long-term complications at timepoints: 2, 5 and 10 years of follow-up and examine if echocardiography - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following covid-19 infection


Eligibility criteria:
inclusion criteria: * all patients hospitalized at hospitals of greater copenhagen area and zealand with a laboratory confirmed diagnosis of covid-19 \> 18 years of age. exclusion criteria: * persons not able to cooperate * persons unable to understand and sign "informed consent"
a investigator masked parallel comparison of tolerability of combigan and cosopt

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the objective of this research study is to compare the tolerability and effectiveness of combigan(brimonidine tartrate/timolol maleate) and cosopt (dorzolamide hydrochloride)in the treatment of open angle glaucoma or ocular hypertension.

patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have been receiving a stable treatment regime for at least 4 weeks prior to the study initiation, with a cosopt mono or a prostaglandin + cosopt combination are to be included in the study.patients must have an iop between 16 and 32 mmhg, with no readings above 35 mmhg at baseline. patients with any other form of glaucoma other than primary open angle glaucoma, with a gonioscopy measured angle grade of less than 2, with a visual field defect not of glaucomatous origen and previous cyclodestructive procedures will be excluded.the use of ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any of the study components also precludes involvement in the study. any ocular laser therapy within the past three months, ocular inflammation or infection in the past three months or any history of trauma in the last six months will also exclude enrollment in the study.

Eligibility criteria:
inclusion criteria: * open angle glaucoma or ocular hypertension including pseudo-exfoliation and pigmentary glaucoma * definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss * a stable treatment regime for at least 4 weeks prior to the study initiation, with a cosopt mono or a prostaglandin + cosopt combination * an iop between 16 and 32 mmhg, with no readings above 35 mmhg at baseline exclusion criteria: * any other form of glaucoma other than primary open angle glaucoma * a gonioscopy measured angle grade of less than 2 * a visual field defect not of glaucomatous origen * previous history of cyclodestructive procedures * the use of ocular non steroidal and anti-inflammatory topical agent that inhibit cyclooxygenase and prostaglandin analog synthesis * the use of glucocorticoid therapy * hypersensitivity to any of the study components * any ocular laser therapy within the past three months * ocular inflammation or infection in the past three months * any history of trauma in the last six months

Keywords: open angle glaucoma ocular hypertension parallel comparison combigan cosopt
evaluation of two different grafting techniques after mandibular impacted third molar surgery

Conditions: Periodontal Pocket; Impacted Third Molar Tooth; Impacted Teeth With Abnormal Position

Summary: this study evaluates the effectiveness of using mineralized plasmatic matrix and β-tricalcium phosphate that placed to extraction socket as a graft material in terms of periodontal damage occurred in the distal aspect of the second molar after mandibular impacted third molar surgery.


Eligibility criteria:
inclusion criteria: * medically healthy. * periodontally healthy patients. * patients with mesioangular or horizontal impacted teeth that will cause periodontal damage at the distal part of the second molar after surgery. exclusion criteria: * crowns on second molar teeth. * poor oral hygiene. * patients with a systemic disease affecting periodontal healing. * pregnancy or lactation period. * patients undergoing orthodontic treatment. * smokers. * the cases where the buccal or lingual cortical bone didn't remain intact following the extraction were also excluded.

Keywords: mineralized plasmatic matrix, beta-tricalcium phosphate
s-1 and photodynamic therapy in cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: in patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. but most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. recently orally available chemotherapeutic agent, s-1 was reported as effective in patients with bile duct adenocarcinoma. the investigators' aims of study evaluate the combined effect of photodynamic therapy and s-1.

in patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary stent has been known for palliation of jaundice and improving survival. but most of therapeutic effects were expected to delay bile duct obstruction rather than to decrease the tumor. recently orally available chemotherapeutic agent, s-1 was reported as effective in patients with bile duct adenocarcinoma. the investigators' aims of study evaluate the combined effect of photodynamic therapy and s-1.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of cholangiocarcinoma * not eligible for curative surgery * eastern cooperative oncology group (ecog) performance status of 2 or better * no serious or uncontrolled concomitant medical illness * adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧75,000/ul) * consent this study in letter exclusion criteria: * another neoplasia * porphyria * pregnant or breastfeeding women

Keywords: cholangiocarcinoma photodynamic therapy s-1
hepatitis c elimination in the netherlands

Conditions: Chronic Hepatitis c

Summary: the aim of celine is to retrieve and re-evaluate lost to follow-up chronic hepatitis c patients in the netherlands.


Eligibility criteria:
inclusion criteria: * ever diagnosed with (possible) chronic hcv in the 15-year period prior to initiation of the study, defined as having had a positive anti-hcv or hcv rna test * lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive hcv test result exclusion criteria: * younger than 18 * deceased * not residing in the netherlands * unknown current address * severe comorbidity or short life expectancy that limits patients from benefiting from retrieval
pi or nnrti as first-line treatment of hiv in west africa - the piona trial

Conditions: HIV-1

Summary: background: since 1996 the combination of three or more drugs has been the mainstay of human immunodeficiency virus (hiv) treatment. the most important types of drugs are called nucleotide reverse transcriptase inhibitors (nrtis), non-nucleotide reverse transcriptase inhibitors (nnrtis) and protease inhibitors (pis) response to treatment is measured as increasing cd4+ cell count and decreasing hiv viral load. a major problem is the development of resistance. nnrtis are recommended as part of first-line treatment of hiv in africa but many africans have a slower nnrti clearance than caucasians making them more susceptible for development of resistance in case of treatment interruptions. pis might therefore be a better option in an african setting with low adherence. aim: to evaluate two different treatment regimens in hiv-1 infected patients: a) a nnrti (efavirenz/nevirapine) based regimen and b) a pi (ritonavir-boosted lopinavir) based regimen with regard to treatment outcomes. hypothesis: treatment with a pi will be superior to treatment with a nnrti due to less development of resistance. methods: treatment-naïve adult hiv-1 patients enrolled in an existing cohort the west african retrovirus and acquired immune deficiency (waraid) cohort in guinea bissau with cd4+ cell count ≤ 350 cells/µl and/or clinical signs of immune suppression (world health organization (who) clinical stage 3 or 4) will be randomised 1:1 to: treatment a: 2 nrtis (lamivudine and either zidovudine or stavudine) and 1 nnrti (efavirenz or nevirapine) or treatment b: 2 nrtis (same as in treatment a) and 1 pi (ritonavir-boosted lopinavir). primary outcome: viral load suppression \<400 copies/ml 12 months after enrolment. perspectives: guidelines for treatment of hiv in africa are more or less a copy of the guidelines used in europe and north america. genetic differences in pharmacokinetics, more women infected in africa and difficulties ensuring good adherence mean that results obtained from caucasian patients are not directly transferrable to african patients. the results of this study will hopefully help guiding the treatment of hiv in africa in the future. the investigators believe the hiv infected people in west africa deserve the same evidence-based medicine as in developed countries.


Eligibility criteria:
inclusion criteria: * antiretroviral treatment (art) naïve hiv-1 infected patients. women receiving art during pregnancy can be included. * age ≥ 18 years * cd4+ cell count ≤ 350 cells/µl and/or * clinical signs of immune suppression (who clinical stage 3 or 4) irrespective of cd4+ cell count. exclusion criteria: * tuberculosis (tb) treatment with rifampicin at the time of enrolment. * co-infection with hiv-2. * grade 3 or 4 alanine transaminase (alat) elevation (\>5 times upper normal limit). * patients with cerebral disturbances that complicates the ability to give informed consent or follow the treatment regime.

Keywords: africa, western antiretroviral therapy, highly active
substudy - low dose of abatacept in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (disease activity score 28 \[das 28\]-erythrocyte sedimentation rate \[esr\] \< 2.6) at day 701 of study im101023.


Eligibility criteria:
inclusion criteria: * subjects who have completed the main study, are willing to participate and have a das 28 esr score of \< 2.6 on day 701 of the main study exclusion criteria: * none

Keywords: nos
a comparative study on the impact of trigger points injection of platelet rich plasma versus botulinum toxin on the relief of jaw muscles myofascial pain

Conditions: Patients with Jaw Muscles Myofascial Pain

Summary: this study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles myofascial pain . the 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin a per trigger point in masseter and/or temporalis muscles. the 2nd group will receive ,5 ml of prp per trigger point in masseter and/or temporalis muscles. the 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles. the 1st follow up session will be after 1 week then 1 month then 3 months . the patients are advised to limit excessive mouth opening, yawning or singing. and when pain episode , theta re advised to take only paracetamol as analgesic drug . at the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , vas to measure the intensity of pain , likert scale , current pain intensity, worst pain intensity and the need to take analgesics in numbers. then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .


Eligibility criteria:
inclusion criteria: * patient with myofascial trigger points in masseter or temporalis previously ----\*identified by manual palpation. * 18 years or more "willingness to follow instructions. exclusion criteria: * therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint. * clinical conditions as pregnancy * medical problems that will interfere with the procedure as bleeding disorders. * cognitive impairment or present inadequate cooperation.
matrifen® for therapy of severe chronic pain®

Conditions: Severe Chronic Pain

Summary: the aim of the study was to evaluate the efficacy and safety of matrifen® in patients with severe and chronic pain who could only be sufficiently treated with opioid analgetics (who class 3).


Eligibility criteria:
main inclusion criteria: * outpatients with severe, chronic pain main exclusion criteria: * hypersensitivity to fentanyl * co-administration of monoamineoxidase-inhibitors * pregnancy * respiratory depression * chronic obstructive pulmonary disease (copd) * drug abuse * impairment of cns functions * other criteria as defined in the summary of product characteristics (chapter 4.3)

Keywords: pain fentanyl transdermal patch
an investigational immuno-therapy safety trial of nivolumab in patients with advanced or metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this study will generate safety data on nivolumab given by itself in treatment of advanced renal cell carcinoma (rcc). the primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (imaes), in patients treated with nivolumab.


Eligibility criteria:
inclusion criteria: * advanced or metastatic renal cell carcinoma (rcc) * predominant clear cell histology: 1. at least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-vegf) treatments 2. no more than 3 total prior systemic treatment regimens in the advanced or metastatic setting 3. subjects with prior treatment with a mechanistic target of rapamycin (mtor) are eligible * non-clear cell histology: 0-3 prior systemic therapies and may include mtor inhibitor * brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation * performance status (ps): ≥ 70% karnofsky performance scale (kps) * all memorial sloan-kettering cancer center (mskcc) prognostic scores allowed exclusion criteria: * subjects with any active autoimmune disease or a history of known autoimmune disease * history of severe hypersensitivity reaction to other monoclonal antibodies * prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured * known hiv or aids-related illness * any positive tests for hepatitis b or hepatitis c virus indicating acute or chronic infection other protocol-defined inclusion/exclusion criteria apply
comparison of continuous feeding and sequential feeding on gut microbiota and metabolomics in critically ill patients

Conditions: Feeding Behavior

Summary: continuous feeding is the most popular enteral feeding mode in the icu because of its lower nursing burden and theoretically better intestinal toleration. however, continuous feeding is nonphysiological. we proposed a feeding mode called sequential feeding, as it utilizes a combination of continuous feeding in the beginning, time-restricted feeding in the second stage, and oral feeding at last. the gut microbiota plays a critical role in human health due to its many useful functions. not only dietary structure but also eating mode (eating time for example) influenced the gut microbiota in a healthy population. therefore, we think this new feeding mode, sequential feeding, also has different influences on gut microbiota and metabolomics in critically ill patients compared to continuous feeding.

nutrition is an important part of therapy for critically ill patients. continuous feeding is the most popular enteral feeding mode in the icu because of its lower nursing burden and theoretically better intestinal toleration. however, continuous feeding is nonphysiological. in our opinion, feeding mode should be changed according to gastrointestinal function and disease progression; one singe feeding mode is not always suitable for critically ill patients. we proposed a feeding mode called sequential feeding, as it utilizes a combination of continuous feeding in the beginning, time-restricted feeding in the second stage, and oral feeding at last. the gut microbiota plays a critical role in human health due to its many useful functions, such as metabolism, vitamin metabolism, and maintenance of the intestinal barrier and immune system. not only dietary structure but also eating mode (eating time for example) influenced the gut microbiota in a healthy population. therefore, we think this new feeding mode, sequential feeding, also has different influences on gut microbiota and metabolomics in critically ill patients compared to continuous feeding.

Eligibility criteria:
inclusion criteria: ●patients newly admitted to the icu and fed through gastric tubes exclusion criteria: * patients with the ability to eat orally at admission * patients with diabetes or gastrointestinal disease * patients who are unable to tolerate enteral feeding * an estimated feeding time of less than 7 days
bloodstram infections in icu. single centre observational study.

Conditions: Bloodstream Infection; Antibiotic Resistant Strain; Intensive Care Unit

Summary: hospital-acquired bloodstream infection (bsi) is serious care problem worldwide associated with significant morbidity and mortality. however, only few nationwide studies have focused on the incidence of bsi, and its results were often inconsistent. the objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population. data were collected in the intensive care unit of the military institute of medicine, warsaw, poland, between january, 1, 2007 and december, 31, 2019.


Eligibility criteria:
inclusion criteria: * all patients hospitalized in the icu with clinically suspected infection. exclusion criteria: * none.